Vitamin B12 Deficiency Clinical Trial
Official title:
Presence of Autoantibodies to Gastric Parietal Cells and Subsequent Vitamin B12 Deficiency in Rheumatoid Arthritis Patients
A review of the literature reveals that very few studies have assessed the potential
co-existence of vitamin B12 deficiency due to gastric parietal cell autoantibodies. While
Segal et al. in 2004 published a study which found that 49% of patients with RA had vitamin
B12 deficiency, no assessment of the etiology or the presence of autoantibodies was made.
While Goeldner et al. in 2011 and Datta et al. in 1990 demonstrated that anti-gastric
parietal cell antibodies (anti-GPC Ab) were found in <5% to 28% of RA patients respectively,
no additional testing was implemented to determine the significance, specifically whether or
not the presence of anti-GPC Ab related to vitamin B12 deficiency.
The purpose of this study is to determine the prevalence and metabolic significance of
anti-GPC Ab in three cohorts: (1) a group of patients with Rheumatoid Arthritis, (2) a group
of patients with autoimmune thyroid disease (AITD), and (3) a group of patients with neither
RA or AITD. To determine the significance of the presence of anti-GPC Ab, testing of the
current serum B12 level along with a metabolite dependent on adequate vitamin B12 levels
(Methylmalonic acid) will be tested.
Background: Organ specific antibodies such as anti-gastric parietal cell antibodies
(anti-GPC Ab) have been found in a variable number of patients with RA, but it is unclear
what significance these antibodies have on actual vitamin B12 levels. Patients with RA have
been found to have vitamin B12 deficiency up to near 50% but it is unclear if this
deficiency is due to anti-GPC Ab.
Hypothesis: By virtue of the aberrant autoimmune process that occurs in RA, patients with RA
are more likely to have anti-GPC Ab and more likely than a control arm or participants with
autoimmune thyroid disease (AITD) to have vitamin B12 deficiency.
Method: 135 patients will be consented; 45 to the RA arm, 45 to an AITD arm, and 45 to a
control arm. Exclusion criteria will filter patients who would have other reasons for
altered vitamin B12 absorption, such as inflammatory bowel disease, surgery, or medication
use. After obtaining consent subjects will be sent to lab a serum anti-GPC Ab test
(obtainable in an SLE panel), RF, B12/folate (as available for ordering in CHCS), methyl
malonic acid, and (for the control arm subjects and AITD subjects) an anti-CCP IgG. Patients
will also complete a one-sided, one page questionnaire asking them about dietary and
medication exposures.
Outcomes: (1) Determine whether evidence of serum vitamin B12 deficiency, as measure by
either a low vitamin B12 level or elevated methylmalonic acid, will be more common in RA
patients with anti-GPC Ab. (2) Determine the prevalence of anti-GPC Ab in a group of
patients with RA as compared to a group of patients with AITD and with no known systemic or
organ specific autoimmune condition.
;
Observational Model: Case Control, Time Perspective: Cross-Sectional
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